View |
|
BR-539
|
Human Coagulation Factor IX
|
Aimafix
|
500IU
|
Lyophilized Powder For Injection
|
Plasma Fraction for Specific Use
|
Kedrion S.P.A
|
Italy
|
Renewal
|
04 April 2019
|
14 January 2029
|
View |
|
BR-540
|
Botulinum Toxin Type A
|
Dysport
|
500 Units
|
Lyophilized Powder for Injection (IM/SC)
|
500 U Lyophilized Powder for Injection (IM/SC)
|
IPSEN Biopharm Ltd.
|
United Kingdom
|
Renewal
|
01 August 2023
|
14 January 2029
|
View |
|
BR-543
|
Human Albumin
|
Kedrialb
|
200g/L (20% w/v)
|
Solution For Iv Infusion
|
Blood Substitutes and Plasma Protein Fractions
|
Kedrion S.P.A.
|
Italy
|
Renewal
|
31 December 2023
|
26 February 2029
|
View |
|
BR-545
|
Epoetin Alfa
|
Wepox 4000
|
4,000 IU/mL
|
Solution for Injection (IV/SC)
|
Antianemic Preparations
|
Wockhardt Ltd.
|
India
|
Initial
|
21 February 2022
|
21 April 2025
|
View |
|
BR-566
|
Factor VIII Purified(Human)
|
Alphanate
|
100 IU/mL (1000 IU/10 mL)
|
Lyophilized Powder for Injection (IV)
|
-
|
Grifols Biologicals, Inc.
|
USA
|
-
|
19 April 2021
|
20 December 2024
|
View |
|
BR-567
|
Hepatitis B Vaccine ( rDNA )
|
Genvac-B
|
10mcg/0.5mL
|
Suspension For Injection(IM)
|
-
|
Serum Institute of India Pvt. Ltd.
|
India
|
-
|
17 January 2022
|
17 January 2025
|
View |
|
BR-568
|
Hepatitis B vaccine (rDNA)
|
None
|
20 mcg/mL
|
Suspension for Injection(IM) (Multidose) (Adult)
|
-
|
Serum Institue of India Ltd.
|
India
|
-
|
29 June 2021
|
17 January 2025
|
View |
|
BR-572
|
BCG Vaccine
|
None
|
None
|
Freeze-Dried Powder For Injection (I.D.)
|
-
|
Serum Institute of India Ltd.
|
India
|
-
|
08 September 2020
|
17 February 2025
|
View |
|
BR-573
|
Factor VIII Purified (Human)
|
Alphanate
|
100 IU/mL (500 IU/mL)
|
Lyophilized Powder for Injection (IV)
|
-
|
Grifols Biologicals, LLC
|
U.S.A
|
-
|
25 March 2022
|
12 October 2024
|
View |
|
BR-574
|
Hepatitis B vaccine (rDNA)
|
Genvac-B
|
20mcg/mL
|
Suspension For Injection (IM) Single Dose (Adult)
|
-
|
Serum Institue of India Pvt. Ltd.
|
India
|
-
|
13 April 2022
|
11 May 2025
|
View |
|
BR-579
|
Filgrastim
|
Neocyte
|
300 mcg/ mL
|
Solution For Injection (Iv/Sc)
|
Hematopoietic Growth Factor
|
Beijing ShuangLu Pharmaceutical Co., Ltd.
|
China
|
Renewal
|
10 May 2024
|
30 May 2029
|
View |
|
BR-580
|
Tuberculin Purified Protein Derivative
|
None
|
5TU/0.1mL
|
Solution For Injection (ID)
|
-
|
Arkay Healthcare Pvt., Ltd.
|
India
|
-
|
12 May 2021
|
08 June 2025
|
View |
|
BR-589
|
Hepatitis B Vaccine ( rDNA)
|
None
|
10mcg/0.5mL
|
Suspension for Injection (IM) (Pediatric)
|
-
|
Serum Institute of India Private Limited
|
India
|
-
|
26 February 2021
|
05 October 2025
|
View |
|
BR-591
|
Tuberculin Purified Protein Derivative
|
None
|
2TU/0.1mL
|
Solution For Injection (Id)
|
Diagnostic Agent
|
Arkray Healthcare Pvt. Ltd.
|
India
|
Renewal (Variation)
|
02 August 2022
|
28 October 2027
|
View |
|
BR-593
|
Alphanine SD 500 IU
|
Coagulation Factor IX (Human)
|
500 IU
|
Lyophilized Powder for Injection (IV)
|
-
|
Grifols Biologicals LLC
|
U.S.A
|
-
|
26 February 2021
|
06 September 2025
|
View |
|
BR-596
|
Bacillus Calmette-Guerin (BCG) Vaccine
|
None
|
250 mcg
|
Freeze-dried Powder for Intradermal Injection
|
Immunostimulant
|
Chengdu Institute of Biological Products
|
China
|
Renewal
|
24 August 2023
|
10 March 2028
|
View |
|
BR-599
|
Human Tetanus Immunoglobulin
|
Tetagam P
|
250 I.U. (100 mg to 170 mg)/mL
|
Solution For Injection (I.M.)
|
-
|
CSL Behring GmbH
|
Germany
|
-
|
28 October 2021
|
12 September 2026
|
View |
|
BR-603
|
Human Papillomavrius Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)
|
Gardasil
|
0.5mL (See Reverse Dosage)
|
Suspension for Injection IM
|
Vaccine
|
Merck Sharp & Dohme Corp.
|
United States of America
|
Renewal
|
30 January 2020
|
19 October 2028
|
View |
BR-613_PI_01.pdf
|
BR-613
|
Tetanus and Diphtheria Toxoids Adsorbed combined with
component Acellular Pertussis Vaccine
|
Adacel
|
Formulation:
Each dose (0.5 mL) contains:
Diphtheria Toxoid Adsorbed-2 Lf
Tetanus Toxoid Adsorbed- 5Lf
Component Acellular Pertussis
Pertussis Toxoid Adsorbed-2.5 mcg
Filamentous Haemagglutinin Adsorbed-5 mcg
Fimbriae Types 2 and 2 Adsorbed-5 mcg
Pertactin Adsorbed-5 mcg
|
Solution For Injection (IM)
|
-
|
Sanofi Pasteur, Inc.
|
Philippines
|
Renewal
|
16 November 2022
|
12 July 2027
|
View |
|
BR-616
|
Human Papillomavirus Vaccine [Types 16, 18]
(Recombinant, Adjuvanted, Adsorbed)
|
Cervarix
|
0.5 mL
|
Suspension For Injection (I.M.)
|
-
|
GlaxoSmithKline Biologicals SA
|
Belgium
|
-
|
16 December 2021
|
07 September 2026
|